Adverse Incidents Involving Medical Devices

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through...

Human Factors Team | FDA

https://www.fda.gov/medical-devices/human-factors-and-medical-devices/human-factors-team

Encourages users and manufacturers to report serious adverse incidents involving medical devices through the FDA's Medical Device Reporting (MDR) …

Learning from adverse incidents involving medical devices

https://pubmed.ncbi.nlm.nih.gov/12715578/

While an adverse event involving a medical device is often ascribed to either user error or device failure, the causes are typically multifactorial. A number of …

Learning from adverse incidents involving …

https://www.bmj.com/content/325/7358/272

Despite efforts of the Medical Devices Agency, which issues safety warnings, adverse incidents with medical devices …

Medical devices: guidance for manufacturers on vigilance

https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance

Medical device incident reporting & investigation scheme …

https://www.tga.gov.au/resources/resource/guidance/medical-device-incident-reporting-investigation-scheme-iris

Medical device incident reporting & investigation scheme (IRIS) Last updated 30 October 2019 Open all | Close all What is an adverse event? What is a near adverse event? …

MHRA Adverse incident reporting | BSIR

https://www.bsir.org/safety-quality/medicines-healthcare-products-regulatory-agency/mhra-adverse-incident-reporting-1/

The role of medical device Safety officers (MDSOs) Over 90% of NHS trusts and social services department have an MDSO. Their key roles are to support local medical device …

Quality improvement report: Learning from adverse …

https://pubmed.ncbi.nlm.nih.gov/12153928/

Despite efforts of the Medical Devices Agency, which issues safety warnings, adverse incidents with medical devices continue to occur, some of which result in serious …

Learning from Adverse Incidents Involving …

https://www.researchgate.net/publication/11228857_Learning_from_Adverse_Incidents_Involving_Medical_Devices

Adverse incidents are typically caused by alignment of different factors, but good practice can prevent errors becoming incidents. Careful analysis of incidents reveals both the...

Report an incident | National Services Scotland

https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/

Submit a report Report adverse incidents and near-misses involving medical devices, in-vitro diagnostic medical devices, estates, facilities, social care equipment and personal …